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Abstract:

Carrying cases for medical devices and components thereof are provided.
Also provided are methods for carrying medical devices and for medical
testing.

Claims:

1. A medical device carrying case for carrying an encased medical device
having an integrated in vitro analyte test strip port, the carrying case
comprising: a housing having a first wall and a second wall; a connector
portion that joins the first and second walls together to provide a
compartment to accommodate a medical device having an integrated in vitro
analyte test strip port; and an in vitro analyte test strip port access
portion provided in the housing, the test strip port access portion
comprising a cut-out that is configured to permit passage of an in vitro
analyte test strip therethrough.

2. The carrying case of claim 1 further comprising a closeable fastener
to selectively interconnect the first and second walls together.

3. The carrying case of claim 2, wherein the closeable fastener comprises
an inter-engageable connector positioned about the perimeters of the
first and second walls.

7. The carrying case of claim 1, wherein the in vitro analyte test strip
port access portion is moveable to selectable positions about the
carrying case.

8. The carrying case of claim 1, wherein the carrying case comprises a
transparent window to permit viewing of the medical device carried in the
carrying case.

9. The carrying case of claim 8, wherein the transparent window is made
of a material that permits manipulation of a user interface of the
medical device carried in the carrying case from outside the carrying
case.

10. The carrying case of claim 1, wherein at least a portion of the
housing comprises a material that permits manipulation of a user
interface of the medical device when carried in the carrying case from
outside the carrying case.

11. The carrying case of claim 1 further comprising an attachment member
to attach the carrying case to an article of clothing.

12. The carrying case of claim 11 wherein the attachment member is
configured to enable the case to be swivelable.

13. The carrying case of claim 1 further comprising a covering to provide
a water-tight seal about the cut-out.

14. An analyte meter carrying system, the system comprising: an analyte
meter comprising an integrated in vitro analyte test strip port and a
user interface; and a carrying case comprising first and second walls
that define a cavity to hold the analyte meter, wherein the carrying case
is configured to allow manipulation of the user interface of the analyte
meter from outside the carrying case when the analyte meter is in the
carrying case.

15. The system of claim 14, wherein the carrying case comprises a test
strip port access portion that is configured to permit passage of an in
vitro analyte test strip therethrough to engage with the in vitro analyte
test strip port of the analyte meter when the analyte meter is in the
carrying case.

16. The system of claim 15, wherein the test strip port access portion
comprises a cut-out.

17. The system of claim 15, wherein the carrying case comprises a
covering to seal the test strip access portion.

18. The system of claim 15, wherein the analyte meter is a component of
an in vivo analyte monitoring system.

19. The system of claim 18, wherein the analyte meter is integrated with
an in vivo analyte monitoring system receiver unit.

20. The system of claim 14, wherein the carrying case further comprises a
stretchable side wall interconnecting the first and second walls.

21. A method of testing for an analyte, the method comprising:
positioning a medical device comprising a test strip port into a carrying
case; inserting a test strip through a test strip access portion of the
carrying case and into the test strip port of the medical device; and
testing for an analyte using the test strip.

22. The method of claim 21 further comprising removing a covering from
the test strip access portion of the carrying case prior to inserting the
test strip.

23. The method of claim 21 wherein positioning the medical device into
the carrying case comprises expanding a stretchable portion of the
carrying case.

24. The method of claim 21 further comprising manipulating a user
interface of the medical device from outside the carrying case.

25. A method of fabricating a carrying case for a medical device, the
method comprising: injecting a first material into a carrying case mold
to produce a case body defining a compartment for receiving the medical
device, the case mold having at least one feature to provide a
corresponding at least one void within the produced case body; and
injecting a second material into the carrying case mold to produce a
user-accessible area at the at least one void of the case body, wherein
the user-accessible area enables user access to the medical device when
operatively positioned within the carry case.

26. The method of claim 25, wherein injecting the first material and
injecting the second material occur independently of each other.

27. The method of claim 25, wherein injecting the first material and
injecting the second material occurs simultaneously.

28. The method of claim 25, wherein the user-accessible area enables
visibility of the medical device.

29. The method of claim 28, wherein the second material is a transparent
material.

30. The method of claim 28, wherein the medical device includes a display
and wherein the user-accessible area of the carrying case is configured
to substantially align with the display of the medical device when the
medical device is operatively positioned within the compartment.

31. The method of claim 25, wherein the user-accessible area enables
manipulation of the medical device.

32. The method of claim 31, wherein the second material is a flexible
material.

33. The method of claim 31, wherein second material has a thickness that
is less than the thickness of first material.

34. The method of claim 31, wherein the medical device includes a user
interface and wherein the user-accessible area of the carrying case is
configured to substantially align with the user interface when the
medical device is operatively positioned within the compartment.

35. The method of claim 34, wherein the user interface includes input
keys and wherein the user-accessible area includes receptacles positioned
for aligning with the input keys.

36. The method of claim 25, wherein the second material includes a
thermoplastic elastomer.

37. The method of claim 25, wherein the first material includes a rigid
plastic material.

38. The method of claim 25, wherein the first material and the second
material are waterproof.

39. The method of claim 25, wherein injecting the second material
provides a water-tight seal between the case body and the user-accessible
area.

40. The method of claim 25, further comprising injecting a third material
into the carrying case mold.

41. The method of claim 40, wherein injecting the third material produces
a second user-accessible area of the medical device at at least one void.

42. The method of claim 25, further comprising providing a sealing member
for enclosing the compartment to provide a water-tight carrying case.

43. The method of claim 25, further comprising forming an attachment
member on an exterior surface of the case body, the attachment member
configured to attach the carrying case to an article of clothing.

44. The method of claim 43, wherein injecting the first material forms
the attachment member.

45. A method of fabricating a carrying case for a medical device, the
method comprising: providing a carrying case mold having at least one
void; providing a plug at the at least one void; injecting at least one
material into the carrying case mold to produce a case body defining a
compartment for receiving the medical device; and removing the plug to
provide a cut-out within the resulting case body, for physically
accessing a portion of the medical device when the medical device is
operatively received within the compartment.

46. The method of claim 45, wherein the medical device comprises an
integrated in vitro analyte test strip port which is accessible via the
cut-out when the medical device is operatively received within the
compartment.

Description:

RELATED APPLICATION

[0001] The present application claims the benefit of U.S. provisional
application No.

[0002] 61/290,856 filed Dec. 29, 2009 entitled "Carrying Cases for Medical
Devices and Methods", the disclosure of which is incorporated herein by
reference for all purposes.

FIELD OF THE DISCLOSURE

[0003] The present disclosure is directed to carrying cases for holding
medical devices. In particular embodiments, the present disclosure is
directed to carrying cases for holding and carrying portable medical
devices such as, but not limited to, one or more components of a
continuous glucose monitoring system.

BACKGROUND

[0004] Analytical analyte testers and meters are often used in chemistry
and medicine to assay for one or more analytes, e.g., to determine the
presence and/or concentration of a biological analyte of interest. For
example, such analytical testers and meters are used to monitor glucose
in diabetic patients and lactate during critical care events.

[0005] A variety of medical devices have been developed so that an
individual may monitor their health outside of a doctor's office or
hospital environment. For example, the home monitoring of analytes by a
user has become increasingly important for disease prevention and
management. In one instance, the level of glucose and/or other analytes,
such as lactate or oxygen, in certain individuals is vitally important to
their health. High or low levels of glucose or other analytes may have
detrimental effects. The monitoring of glucose is particularly important
to individuals with diabetes, e.g., in some instances a diabetic must
determine when insulin is needed to be administered to reduce glucose
levels in their bodies or when additional glucose is needed to raise the
level of glucose in their bodies.

[0006] Conventional techniques for monitoring blood glucose levels include
the use of an in vitro analyte tester and associated reader. This in
vitro technique involves the periodic obtaining of a biological sample,
the application of that sample to an in vitro analyte test strip, and the
determination of the analyte, such as glucose, concentration from the
sample using, for example electrochemical, colorimetric, or photometric
techniques, using an in vitro analyte test strip reader or meter (also
referred to as a monitor, and the like). This technique is commonly
referred to as in vitro or ex-vivo or discrete testing in that the
analyte test strip is outside of the body of a user and the sample is
removed or extracted from the body and applied to the test strip for
analysis.

[0007] The components of in vitro analyte systems can vary, but may
include a plurality of analyte test strips, such as provided in a test
strip cartridge, a test strip meter used to read the test strip and a
lancing device which may or may not be integrated with the meter.
Examples include the FreeStyle® and Precision® brands of analyte
testing systems from Abbott Diabetes Care Inc. of Alameda, Calif.

[0008] Also developed for analyte testing are continuous or in vivo
monitoring systems in which at least a portion of an analyte sensor is
positioned for a period of time beneath the skin of a user so as to be in
direct contact with biological fluid during the period of time. Using
such in vivo monitoring systems, analyte monitoring is achieved with the
in vivo analyte sensor, transcutaneously positioned or wholly implanted,
or otherwise maintained in fluid contact with the biological fluid over
the period of monitoring time, and analyte-related signals are obtained
semi-continuously or substantially continuously over a period of time at
predetermined time intervals such as once every minute, or once every
five minutes or longer or shorter, as opposed to at discrete time points
as in the case of testing with in vitro systems, where the discrete time
points are based on when the user decides to use the in vitro system.

[0009] The components of in vivo analyte systems can vary, but may include
an in vivo analyte sensor, a sensor control unit configured for direct or
indirect electrical contact with the in vivo sensor, and a receiver unit
or monitor to receive communication from the sensor control unit, e.g.,
wirelessly by radio frequency (RF), infrared (IR), or the like, or with a
wired connection using a cable. An example of a continuous glucose
monitoring system includes the FreeStyle Navigator® continuous
glucose monitoring system from Abbott Diabetes Care Inc. of Alameda,
Calif.

[0010] Users of in vivo monitoring systems often continue to use in vitro
analyte systems in conjunction with the in vivo monitoring system, e.g.,
to calibrate and/or confirm information obtained from the in vivo
systems.

[0011] Users of either or both in vitro and in vivo analyte monitoring
systems may be required to carry with them multiple system components,
which is inconvenient. For example, sensor control units of in vivo
monitoring systems may be configured to be positioned for a period of
time on the body of a user either directly or using a mounting unit and
in electrical communication with the in vivo analyte sensor, either of
which may include an adhesive or other attachment feature for attachment
to skin. However, one or more other components of the system may still
need to be carried, such as the receiver unit which includes the user
interface to output or present information to the patient or the user of
the in vivo monitoring systems, as well as components of the in vitro
analyte measurement system, if used. Furthermore, existing systems or
system components carrying techniques are often cumbersome, fragile, and
do not promote inconspicuous testing. There is also a need to prevent
water or moisture from contacting one or more components of the system
described above.

[0012] Accordingly, as analyte testing or monitoring outside of clinical
settings continues to be of importance in health management, there is a
need for carrying cases that provide a compact, convenient, and discrete
way for a user to carry and use equipment necessary to conduct analyte
testing or monitoring. Also of interest are carrying cases that protect a
carried medical device from environmental factors such as water,
moisture, contaminants, debris, or the like.

SUMMARY

[0013] Embodiments of the present disclosure include carrying cases and
methods for carrying one or more portable medical devices or one or more
components of medical devices or systems, e.g., medical devices used for
analyte testing of a biological fluid, as well as methods of analyte
testing.

[0014] Certain embodiments of the medical device carrying cases described
herein include features to allow convenient visual and/or physical access
to at least a portion of the carried medical device without having to
remove the medical device from the carrying case. The subject cases are
suitable for carrying, for example, portable analyte testing medical
devices that include visual displays and/or an integrated in vitro
analyte test strip ports and/or other connections. Many embodiments
include features such that a carried medical device may be accessed via
an access portion of a closed carrying case without having to open the
carrying case.

[0015] In certain embodiments, the medical device carrying case is
configured to carry a medical device having an integrated in vitro
analyte test strip port, and in one embodiment includes a housing having
a first wall and a second wall, a connector portion that joins the first
and second walls together to provide a cavity to accommodate a medical
device having an integrated in vitro analyte test strip port, and an in
vitro analyte test strip port access portion comprising a cut-out that is
configured to permit passage of an in vitro analyte test strip
therethrough.

[0016] An analyte meter carrying system in another aspect of the present
disclosure includes an analyte meter comprising an integrated in vitro
analyte test strip port and a user interface, and a water-tight carrying
case comprising first and second walls that define a cavity to hold the
analyte meter, wherein the carrying case is configured to allow
manipulation of the user interface of the analyte meter from outside the
carrying case when the analyte meter is in the carrying case.

[0017] Embodiments also include carrying cases and methods of carrying
medical devices that provide a barrier between a carried medical device
and the environment to prevent environmental factors from contacting the
medical device, e.g., water tight or sealed carrying cases to prevent or
minimize moisture or contaminants from contacting the medical device.
Examples of medical devices that may be used with the carrying cases
described herein include, but are not limited to, one or more components
of an in vitro analyte testing system such as in vitro glucose meters,
one or more components of in vivo analyte monitoring systems (e.g.,
receiver/display units) e.g., in vivo components that have integrated in
vitro meters, and drug delivery pumps, including drug delivery pumps that
have integrated in vivo analyte monitoring components and/or in vitro
analyte components, and the like.

[0018] Certain embodiments include carrying cases having a housing having
a first or frontal wall and an opposing second or rear wall. The two
walls may be releasably coupled together by a connection portion to form
a body having a hollow cavity shaped and dimensioned to accommodate and
securely hold a medical device within the cavity. The connection portion
may include a closeable fastener to selectively interconnect the first
and second walls together. The closeable fastener may comprise an
inter-engageable connector positioned about the perimeters of the first
and second walls. The inter-engageable connector may comprise a zipper.
The zipper may comprise dual sliders that move independently of each
other.

[0019] In certain embodiments, at least a portion of the housing may
comprise a material that permits manipulation of a user interface of the
medical device carried in the carrying case from outside the carrying
case. In particular embodiments, the frontal wall of the carrying case
may be characterized as a user interface wall as it aligns with and
covers a user interface of a carried medical device when the medical
device is carried in the case. User interface features of a medical
device include features that enable communication between (to and/or
from) a user and the medical device, including one or more elements with
which a user operates or uses the device or the component of the device
in order to carry out analyte testing and include, but are not limited
to, visual displays and/or actuators (by way of buttons, knobs, levers,
wheels, touch screens, or the like). In certain embodiments, the user
interface of the medical device is configured for operation or
manipulation by the user while the medical device is in the case, e.g.,
through the viewing window of the carrying case. For example, the viewing
window may include material that permits a user to manipulate the user
interface of a carried medical device by contacting the viewing window
which may be caused to contact or otherwise interact with a given user
interface element. Embodiments of the carrying cases include a test strip
port access portion that surrounds an in vitro test strip port of a
medical device carried by the case.

[0020] Embodiments may also include an attachment member to attach a
carrying case to a user, e.g., to clothing such as a belt or handbag.
Attachment members may be secured, for example, to the second wall of the
carrying case so that the user interface of the carrying case, and
correspondingly the user interface of a carried medical device, may be
accessible and viewable (when provided with a viewable interface) without
removing the medical device from the carrying case, when the carrying
case attachment member is attached to a user. Attachment members may also
be secured so that an in vitro analyte test strip port of a carried
medical device may be accessed with an in vitro analyte test strip
without removing the medical device from the carrying case, when the
carrying case attachment member is attached to a user.

[0021] The carrying case may comprise an in vitro analyte test strip port
access portion that is configured to permit passage of an in vitro
analyte test strip therethrough to engage with the test strip port of the
medical device when the medical device is held in the carrying case. In
certain embodiments, the in vitro analyte test strip port access portion
may be immoveable, while in other embodiments, the in vitro analyte test
strip port access portion may be moveable to selectable positions about
the carrying case. The test strip port access portion may comprise a
cut-out. The carrying case may comprise a covering or cap to seal the in
vitro analyte test strip access portion.

[0022] The present disclosure also provides for methods involving the use
of the medical device operatively carried within the subject carrying
cases. Certain methods include testing for an analyte which may include
positioning a medical device comprising a test strip port into a carrying
case, inserting a test strip through a test strip access portion of the
carrying case and into the test strip port of the medical device, and
testing for a concentration of an analyte sample on the test strip using
the medical device.

[0023] Other methods provided in the present disclosure include methods of
fabricating the subject carrying cases which may involve an injection
molding process including multiple injection steps. In certain methods,
such a process includes injecting a first material into a carrying case
mold to produce a case body defining a compartment for receiving the
medical device, the case mold having at least one feature to provide a
corresponding at least one void within the produced case body and
injecting a second material into the carrying case mold to produce a
user-accessible area at the at least one void of the case body, wherein
the user-accessible area enables user access of the medical device when
operatively positioned within the carry case. The first and second
injecting steps may occur at different times or simultaneously. The first
and second materials may have the same or different opacity and/or the
same or different rigidity/flexibility. The user accessible areas may
enable visibility of, or physical access to, the medical device (such as
visibility of a display on the device or manipulation of interface keys,
e.g., buttons on a user interface of the device). Such methods may also
include three, four or more injecting steps of the same or different
materials.

[0024] Another fabrication method of the present disclosure includes
providing a carrying case mold having at least one void, providing a plug
at the at least one void, injecting at least one material into the
carrying case mold to produce a case body defining a compartment for
receiving the medical device, and removing the plug to provide a cut-out
within the resulting case body, wherein the cut-out for physically
accessing a portion of the medical device when operatively received
within the compartment. In certain embodiments, the medical device
comprises an integrated in vitro analyte test strip port which is
accessible via the cut-out when the medical device is operatively
received within the compartment.

[0025] These and other features, objects and advantages of the present
disclosure will become apparent to those persons skilled in the art upon
reading the details of the present disclosure as more fully described
below.

[0027] Referring now to the drawings, wherein like reference numerals and
letters indicate corresponding structure throughout the several views:

[0028] FIGS. 1A-1D show an exemplary embodiment of a medical device
carrying case according to the subject disclosure, where FIG. 1A shows a
frontal view of the medical device carrying case according to the present
disclosure having an in vitro analyte test strip port access portion,
FIG. 1B is a perspective view of the case of FIG. 1A showing the medical
device securely fastened inside the case, FIG. 1c shows a rear view of
the case of FIG. 1A having an attachment member in the form of a clip
portion, and FIG. 1D is a view of the perimeter of the case of FIG. 1A in
a closed state;

[0029]FIG. 2 shows a perspective view of an exemplary embodiment of a
medical device carrying case according to the subject disclosure having a
deformable side wall;

[0030]FIG. 3 shows a frontal view of an exemplary embodiment of a medical
device carrying case according to the subject disclosure having a privacy
shroud to releasably shroud at least a portion of the carrying case;

[0031] FIGS. 4A-4C show a rear view of an exemplary embodiment of a
water-tight medical device carrying case according to the subject
disclosure, where FIG. 4A shows an isometric, exploded view of the
water-tight medical device carrying case; FIG. 4B shows a frontal view of
the water-tight medical device carrying case in a water-tight sealed
configuration; and FIG. 4c shows a side view of the water-tight medical
device carrying case with an exploded view of a portion of a wall of the
case; and

[0032] FIGS. 5A-5B show another exemplary embodiment of a medical device
carrying case according to the subject disclosure.

DETAILED DESCRIPTION

[0033] Before the present disclosure is further described, it is to be
understood that the present disclosure is not limited to particular
embodiments described, as such may, of course, vary. It is also to be
understood that the terminology used herein is for the purpose of
describing particular embodiments only, and is not intended to be
limiting, since the scope of the present disclosure will be limited only
by the appended claims.

[0034] As will be apparent to those of skill in the art upon reading this
disclosure, each of the individual embodiments described and illustrated
herein has discrete components and features which may be readily
separated from or combined with the features of any of the other several
embodiments without departing from the scope or spirit of the present
disclosure.

[0035] Where a range of values is provided, it is understood that each
intervening value, to the tenth of the unit of the lower limit unless the
context clearly dictates otherwise, between the upper and lower limit of
that range and any other stated or intervening value in that stated
range, is encompassed within the disclosure. The upper and lower limits
of these smaller ranges may independently be included in the smaller
ranges, and are also encompassed within the disclosure, subject to any
specifically excluded limit in the stated range. Where the stated range
includes one or both of the limits, ranges excluding either or both of
those included limits are also included in the disclosure.

[0036] Unless defined otherwise, all technical and scientific terms used
herein have the same meaning as commonly understood by one of ordinary
skill in the art to which this disclosure belongs. Although any methods
and materials similar or equivalent to those described herein can also be
used in the practice or testing of the present disclosure, exemplary
methods and materials are now described. All publications mentioned
herein are incorporated herein by reference to disclose and describe the
methods and/or materials in connection with which the publications are
cited.

[0037] As used herein and in the appended claims, the singular forms "a,"
"an," and "the" include plural referents unless the context clearly
dictates otherwise. It is further noted that the claims may be drafted to
exclude any optional element. As such, this statement is intended to
serve as antecedent basis for use of such exclusive terminology as
"solely," "only" and the like in connection with the recitation of claim
elements, or use of a "negative" limitation.

[0038] The publications discussed herein are provided solely for their
disclosure prior to the filing date of the present application. Nothing
herein is to be construed as an admission that the present disclosure is
not entitled to antedate such publication by virtue of prior disclosure.
Further, the dates of publication provided may be different from the
actual publication dates which may need to be independently confirmed.

[0039] It is to be understood and will be apparent to those of skill in
the art that the embodiments of the subject disclosure may be applicable
to carrying a variety of medical devices, e.g., medical device components
that include integrated in vitro analyte test strip ports. Certain
embodiments of the carrying cases are configured to receive and securely
hold or retain in vitro analyte meters (also referred to as single point
monitors, single point blood glucose modules, blood glucose monitors or
meters, and the like). Other embodiments are described with respect to
carrying a component of an in vivo analyte monitoring system, e.g., that
includes an integrated in vitro analyte testing system having an in vitro
analyte test strip port (i.e., integrated in vivo analyte monitoring
system components such as integrated in vivo analyte receiver unit
housing that includes an in vitro test strip port). In particular, and in
many embodiments, the in vitro analyte meters are combined with in vivo
analyte monitoring systems to provide an integrated analyte monitoring
system to monitor an analyte in vivo and/or in vitro.

[0040] Embodiments of carrying cases having integrated in vitro analyte
test strip port access portions to align about and provide direct access
to an in vitro analyte test strip port of a carried medical device are
described. The in vitro analyte test strip port access portion may
include a cut-out configured to accommodate an in vitro analyte test
strip therethrough so that the in vitro analyte test strip is insertable
into the in vitro analyte test strip port of the medical device carried
by the carrying case without removal of the medical device from the
carrying case. In many embodiments, the cut-out is the only opening or
access point to the test strip port of a carried medical device when the
carrying case is fully closed around the medical device. The in vitro
analyte test strip port access portion of the carrying case may be
positioned in a variety of positions about the carrying case, e.g., about
the perimeter of the case. In certain embodiments, the in vitro analyte
test strip port access portion is fixed in place on the carrying case
(i.e., immovable), and in certain other embodiments the in vitro analyte
test strip port access portion is moveable (e.g., slidable), about the
carrying case to a plurality of selectable positions.

[0041] Embodiments of the subject carrying cases are suitable for use with
standalone in vitro analyte meters. The components of in vitro analyte
systems can vary, but may include a plurality of analyte test strips,
such as provided in a test strip cartridge, a test strip meter used to
read the test strip and a lancing device which may or may not be
integrated with the meter. Examples of in vitro analyte systems are
described, e.g., in U.S. Pat. No. 7,041,468 and in U.S. Publication Nos.
2010/0204557 and 2010/0198142, the disclosures of each of which are
herein incorporated by reference for all purposes.

[0042] The subject carry cases are also suitable for us with in vitro
meters which are integrated with a housing of a component of an in vivo
system, e.g., integrated into a housing of an in vivo sensor control unit
and/or an in vivo receiver unit, and/or an in vivo mounting unit, or
other. In vivo analyte monitoring systems include, for example, an in
vivo analyte sensor (e.g., glucose sensor, ketone sensor, etc.) that is
configured to be at least partially implanted in a user and in contact
with biological fluid for a period of time, to monitor the analyte level
in the contacted biological fluid semi-continuously or continuously over
the period of time. During this period of time of in vivo analyte
monitoring, separate user initiated discrete in vitro testing may be
performed. For example, analyte results obtained from in vitro testing
may be used to calibrate the in vivo system and/or may be used to
periodically confirm results of an in vivo system, e.g., prior to relying
on the results obtained by the in vivo analyte system. In vivo analyte
systems with integrated in vitro analyte systems such as integrated
calibrators, including integrated in vitro analyte test strip ports, are
described, e.g., in U.S. Pat. Nos. 4,545,382; 4,711,245; 5,262,035;
5,262,305; 5,264,104; 5,320,715; 5,509,410; 5,543,326; 5,593,852;
5,601,435; 5,628,890; 5,820,551; 5,822,715; 5,899,855; 5,918,603;
6,071,391; 6,103,033; 6,120,676; 6,121,009; 6,134,461; 6,143,164;
6,144,837; 6,161,095; 6,175,752; 6,270,455; 6,284,478; 6,299,757;
6,338,790; 6,377,894; 6,461,496; 6,503,381; 6,514,460; 6,514,718;
6,540,891; 6,560,471; 6,579,690; 6,591,125; 6,592,745; 6,600,997;
6,605,200; 6,605,201; 6,616,819; 6,618,934; 6,650,471; 6,654,625;
6,676,816; 6,676,819; 6,730,200; 6,736,957; 6,746,582; . 6,749,740;
6,764,581; 6,773,671; 6,881,551; 6,893,545; 6,932,892; 6,932,894;
6,942,518; 7,167,818; and 7,299,082; U.S. Published Application Nos.
2004/0186365; 2005/0182306; 2007/0056858; 2007/0068807; 2007/0227911;
2007/0233013; 2008/0081977; 2008/0161666; and 2009/0054748; U.S. patent
application Ser. Nos. 12/131,012; 12/242,823; 12/363,712; 12/495,798;
12/495,803; and Ser. Nos. 12/495,807; 12/698,124; 12/714,439; 12/807,278;
12/842,013; and 12/848,075, the disclosures of each of which are herein
incorporated by reference for all purposes.

[0043] Referring now to the figures and to FIGS. 1A-1D in particular,
there is shown an embodiment of an analyte monitoring system including a
medical device carrying case 100 that accommodates an in vitro analyte
test strip 50 through a surface of the case, and a medical device 500.

[0044] Medical device 500 is shown in the embodiment of FIGS. 1A-1D as an
in vivo analyte monitoring system component, and more specifically as a
receiver unit of an in vivo analyte monitoring system such as in the form
of a portable, hand-held pager-like receiver unit that receives analyte
data from another component of an in vivo system. For example, such a
receiver unit may be configured to communicate with a transmitter unit of
an in vivo analyte system (not shown) such as a sensor control unit or
the like (uni- or bi-directionally). Communication may be automatic
(without any action to initiate transmissions other than initialization
of the system and may be at least semi-continuous automatic broadcasts),
or communication may be on-demand such that data communication only
occurs upon action of a user to cause the data transfer such as
requesting data transfer (see for example U.S. patent application Ser.
Nos. 12/143,731, 12/143,734, 12/698,124, 12/730,193, and 12/807,278, the
disclosures of which are herein incorporated by reference). Receiver unit
500 may include a user interface 510, and user interface 510 may include
a display module 502. It is to be understood that receiver unit 500 may
not include a user interface and/or may not include a display in certain
embodiments.

[0045] Medical device carrying case 100, according to one or more
embodiments, includes a housing 108 having a frontal or first wall 101
and a second or rear or back wall 102 (the latter being best viewed in
FIG. 1B). The two walls may be foldably or movably joined together at
connector portion 103, and an in vitro analyte test strip port access
portion 105 that includes a test strip aperture 125 configured to align
with an in vitro test strip port 501 of a medical device 500, such as a
component of an in vivo analyte system (or of an in vitro analyte meter
that is not integrated in an in vivo system). Case 100 and port access
portion 105 of the case are configured so that the in vitro analyte test
strip port 501 of medical device 500 registers with the port access
portion 105 upon positioning the medical device 500 within the case 100.
Accordingly, when device 500 is held, positioned or carried within case
100, the aligned test strip port 501 of the in vivo system (or of an in
vitro analyte meter that is not integrated in an in vivo system) is
accessible through the in vitro analyte test strip port access portion
105 of the carrying case 100. FIG. 1A shows a frontal view orientation of
medical device 500 and carrying case 100 in which medical device 500 is
shown outside case 100 and oriented to be inserted into case 100 to
register the integrated in vitro analyte test strip port 501 of the
medical device 500 with in vitro analyte test strip port access portion
105 of the case. FIG. 1B shows medical device 500 securely fastened
within case 100.

[0046] Port access portion 105 includes a cut-out or aperture 125 to
provide access to a test strip port 501 of a medical device 500 inserted
in case 100. Port access portion 105 may include an area, e.g., an area
of a textile, elastomer, etc., that includes test strip aperture 125 to
align with and substantially surround an in vitro analyte test strip port
501 of carried medical device 500 when positioned and secured within the
case. Accordingly, cut-out 125 is dimensioned and positioned to permit
entry of an in vitro analyte test strip 50 through cut-out 125 and into
an in vitro test strip port 501 of medical device 500 when the medical
device 500 is disposed in the cavity of the carrying case 100. Cut-out
125 may include a covering, e.g., a cap, a plug or the like, to cover
cut-out 125 when not needed, e.g., between analyte testing with in vitro
analyte test strips 50, and to provide access to an underlying test strip
port 501 of an in vitro analyte meter 500 when uncovered. Access portion
105 may be positioned in any suitable location about the carrying case
100. In certain embodiments, access portion 105 is positioned on a side
or perimeter portion of the case as shown in the embodiments of FIGS.
1A-1D, and in other embodiments it is positioned in a wall of the case
100.

[0047] Carrying case housing 108 defines a cavity or pocket into which
medical device 500 may be positioned. Housing 108, at least in part, is
defined by a first or frontal wall 101 and a second or rear wall 102,
which may be opened and closed to provide access to and closure of the
cavity so medical device 500 may be securely held within and removed from
the housing 108. Walls 101 and 102 may be permanently and/or selectively
interconnected to each other. In certain embodiments, the walls are
interconnected by way of a fixed or permanent connector 103 that
permanently connects front wall 101 and rear wall 102 together. Connector
103 includes one or more permanent attachment area(s) that join walls 101
and 102 together at at least one location along the walls' perimeter. In
certain embodiments, walls 101/102 are further connectable around their
peripheral edges to form the desired shape and interior cavity or pocket.
The remainders of the perimeter of the walls 101/102 are inter-engageable
and dis-engageable to open and close the case. Connector portion 103 may
be flexible or rigid material such as a textile material, stitching, and
the like, or may be an extension of one or both walls 101/102. Upon
complete closure of the case 100 in many embodiments, access portion 105
may provide the only area of the case 100 through which an in vitro
analyte test strip 50 may be accommodated for insertion therethrough. In
certain embodiments, access portion 105 is formed by or upon
inter-engaging walls 101 and 102 together. In certain embodiments,
connector portion 103 may include access portion 105, and in certain
other embodiments, port access portion 105 may be separate from, e.g.,
spaced apart from, connector portion 103.

[0048] Walls 101 and 102 may be further selectively interconnected about
their perimeters with a closeable fastener such as an inter-engageable
connector 104 provided around the periphery of the walls 101/102 in
peripheral areas that lack connector portion 103 and/or access portion
105, such that the walls may be selectively inter-engaged together with
the inter-engageable connector (see, e.g., FIGS. 1A-1D which show
portions of the perimeter of case 100 closed with inter-engageable
connector 104). The walls of the case may be selectively interconnected
using any suitable inter-engageable connector, including, but not limited
to, one or more of zippers, latches, snaps, inter-engaging hook and loop
material (e.g., Velcro®, or the like), hooks, and the like, and
combinations thereof.

[0049] The embodiments of FIGS. 1A-1D show inter-engageable connector 104
in the form of a zipper unit. Zipper unit may extend partially or
completely around the perimeter or edges of the carrying case, with the
exception of connector portion 103 and/or in vitro analyte test strip
port access portion 105 if such would prevent positioning of connector
104. As shown in FIG. 1D, zipper units may include a first closure panel
140a (e.g., a stringer) that includes first tape and teeth assembly 145a
positioned about the periphery of first wall 101, and inter-engageable
second closure panel 140b (e.g., a second stringer) that includes second
tape and teeth assembly 145b positioned about the periphery of second
wall 102. As shown in the figures, walls 101,102 have co-operable zipper
teeth around their peripheries. At least one slider 106 is positioned on
both first and second teeth assemblies, and the at least one slider 106
is moveable along the teeth assemblies to correspondingly
engage/disengage the inter-engageable teeth assemblies (or uncouple the
teeth assemblies). A slider may include a user-engageable tab 106a. One
or more stops are included to maintain a slider on the teeth assemblies.
Connector portion 103 and/or in vitro analyte test strip port access
portion 105 may include a stop.

[0050] In certain embodiments, a zipper unit may include dual sliders.
Dual sliders 106 and 106' are shown for example in the embodiment of
FIGS. 1A and 1C. The dual sliders 106 and 106' move independently of each
other to open and close the carrying case 100, and each may move in one
or any direction about the carrying case 100. The dual sliders 106 and
106' are each positioned on both first and second teeth assemblies
145a/145b and are moveable along the panels in a clockwise and/or
counterclockwise direction to cause connecting or disconnecting of the
teeth assemblies 145a/145b, and therefore of the two walls 101/102 of the
case. In certain embodiments, the dual sliders 106 and 106' are
positioned adjacent to each other when the carrying case 100 is closed,
and spaced apart when the carrying case 100 is open to provide access to
the internal cavity of the carrying case 100, for example for insertion
or removal of medical device 500.

[0051] In certain embodiments, the carrying cases are constructed to
position a carried medical device in a particular orientation with
respect to a user to make using (e.g., viewing and/or test strip testing,
etc.) convenient, for example by minimizing the amount of manipulation of
the case and/or carried device. As shown in FIG. 1A, the components
100/500 of the system are oriented relative to each other so that case
100 can be clipped to an article of clothing (e.g., a belt, purse, or the
like), and when medical device 500 is inserted into and secured in the
case 100 so that in vitro analyte test strip port access 105 of the
carrying case is aligned with the port 501 of receiver unit 500, the
orientation of medical device 500 is such that the visual display module
502 of the receiver/display unit is upside down or inverted relative to
the user 190 when the case is attached to, e.g., a belt, and the user 190
is looking downward at the system 100/500. More particularly, case 100
may be constructed so that second wall 102 is closest to a user's body
when the case is attached to the user, e.g., to a user's belt, and
frontal wall 101 faces away from user's body. In this manner, a user is
able to view device display 502 in a convenient "right side up"
orientation by grasping case 100 having medical device 500 therein and
pivoting it upwards towards the user's field of vision while the case
remains clipped to the clothing. When so pivoted, display module 502 will
be "right side up" to the user. This described positioning of the medical
device 500 in the case and orientation relative to a user 190 is
exemplary only as a variety of orientations are envisioned.

[0052] In certain embodiments, frontal wall 101 includes an optional
window 107, for viewing a user interface 510 of carried medical device
500 such as a visual display 502, or the like. Window 107 may be an
opening in wall 101, or may include a transparent shroud, e.g., a
transparent material, e.g., a transparent plastic or the like, and may be
flexible or rigid. A transparent shroud may be any suitable material,
e.g., scratch resistant and/or moisture resistant material.

[0053]FIG. 1c shows a planar view of second or rear or back wall 102 of
case 100. Rear wall 102 includes an attachment member 110 in this
embodiment. Attachment member 110 is mounted to wall 102 by a mount 111
or may be part of wall 102, e.g., an extension thereof, sewn in place,
etc., and is removably attachable to an article of clothing such as a
belt. Attachment member 110 may be permanently attached to wall 102, or
may be attachable to and removable from the case 100 by a user.
Attachment member 110 may include a clip portion. For example, an
attachment member may include a first leg portion attached to rear wall
102, connected to a second leg, e.g., by a transition portion (e.g., a
U-shape transition or the like). The second leg may be biased towards
rear wall 102. An article of clothing may be positioned between the first
and second legs to attach case 100 to the article of clothing. Attachment
members include, but are not limited to, S-clips, U-clips, and the like.
An attachment member 110 may include one or more barbs for securement to
clothing. In certain embodiments, case 100 may be swivelable. For
example, the connection between the case 100 and the attachment member
110 may allow the case 100 to swivel about a swivel point. A swivel
attachment member 110 may therefore be configured to be attachable to an
article of clothing and to a medical device carrying case 100 to permit
the carrying case 100 to swivel about a swivel point from about 0°
to about 360°, e.g., from about 0° to about 180° in
certain embodiments. In certain embodiments, a locking mechanism is
included to permit carrying case to selectively swivel and lock in a
variety of pre-selected positions, e.g., anywhere between about 0°
to about 360°, for ease of use and movement until a user adjusts
the case to another position (e.g., by a light push of a finger), for
example. Such attachment systems may include a ratchet and pawl, high
friction rotary joints, or the like. The attachment member 110 may
include a release button (not shown) for selectively coupling and
releasing the case 100 and the attachment member 110.

[0054] As further shown in FIG. 1c, in certain embodiments, case 100 may
include storage area 109 such as located on the front 101 and/or rear 102
walls (in or on an interior and/or exterior surface of one or both of the
walls 101/102), to hold components for use with medical device 500, e.g.,
one or more components of an analyte testing system such as new and/or
used test strips and/or new and/or used lancets and/or lancing devices
and/or control solutions and/or drug administration devices (e.g.,
syringes, pen-type injectors, and the like).

[0055] Front and rear walls 101/102 may be any suitable material. The
walls may include the same or different material, or may include some
same and some different materials. The walls 101/102 may be flexible or
rigid, and may include some flexible and some rigid material, e.g., a
given wall may include one or more materials of differing
softness/hardness. One or both of walls 101 and 102 may include flexible,
deformable material, e.g., a textile, or the like. In certain
embodiments, material may include a flexible and/or crushable and/or
water proof material. In certain embodiments, the case is constructed of
a substantially deformable material which is capable of absorbing shock
delivered to the case. Examples of materials that may be employed
include, but are not limited to, fabric, plastic, leather, elastic,
nylon, neoprene, e.g., neoprene rubber secured between two layers of
nylon, etc., and combinations thereof. In certain embodiments, case 100
or portions thereof are rigid and include hard material such as rigid
plastic, or one or more polymers. For example, at least the perimeter of
aperture 125 may include a material that is easy to disinfect, e.g., a
hard elastomeric material or the like.

[0056]FIG. 2 shows another embodiment of a carrying case 200 that
includes one or more stretchable side or peripheral walls 212 that join
at least a portion of the peripheries of front and rear walls of the
carrying case together. The stretchable side walls are configured to
stretch, e.g., may include a stretchable textile such as an elastic
material, or the like. As shown in FIG. 2, similar to case 100 of FIGS.
1A-1D, case 200 includes first and second walls 201/202, and in vitro
analyte test strip port access portion 205 having a cut-out 225 to
provide access to a test strip port of a medical device inserted in case
200. However, in this embodiment, walls 201 and 202 are joined about a
portion of their peripheries by stretchable side wall 212. A portion of
the periphery of the carry case includes a clearance 217 which is void of
any stretchable side wall and which is dimensioned to permit insertion
and removal of a medical device into case 200, and specifically between
walls 201 and 202. Insertion of a medical device, such as by way of
clearance 217, may cause stretchable side walls to stretch or expand so
that a medical device is secured within the walls of the case as the
stretchable side walls relax back upon the medical device to restrain the
medical device within case 200. For example, the act of insertion of a
medical device may cause expansion of the side walls and accommodation of
the device into the case. In certain embodiments case 200 may include one
or more of a lip 213, e.g., a rigid lip, to further secure a medical
device in the case by providing a raised barrier. Rigid lip 213 may
extend around all or part of periphery of case 200. Test strip access
portion 205 and cut-out 225 may be omitted in certain embodiments and
clearance 217 may serve as a test strip port access portion.

[0057]FIG. 3 shows an embodiment of a medical device carrying case 300
that includes a removable privacy shroud 360 to cover a window 307 of the
carrying case 300. For example, shroud 360 may be opaque. As shown in
FIG. 3, similar to cases 100 and 200 of FIGS. 1A-1D and 2, case 300
includes first and second walls 301/302, and in vitro analyte test strip
port access portion 305 having a cut-out 325 to provide access to a test
strip port of a medical device inserted in case 300. Shroud 360 is
positioned proximate to window 307 and is selectively activateable to
substantially cover and/or protect window 307, and in certain embodiments
may assist in restraining a medical unit within the case. Shroud 360 may
also protect the interior of carrying case 300 (and retained medical
device) from environmental elements, e.g., if window 307 is an opening to
the interior of the case.

[0058] FIGS. 4A-4C show an embodiment of a water proof medical device
carrying case 400 that includes a body 430 and mateable cap 450, which
when coupled together provide a water tight seal. Carrying case 400
provides a compartment 460 formed by first or frontal wall 401 and second
or rear wall 402 and side wall connector portion 403, which may be rigid
in many embodiments, to house a medical device and protect it from
environmental factors such as water, debris, etc. Carrying case 400 may
be clear or opaque (e.g., injection or blown) and may be flexible or
rigid, or include flexible portion(s) and rigid portion(s). For example,
rigid portions may be used to protect a medical device held inside and
flexible portions may be used to allow manipulation of the device from
outside the case. Body 430 may include one or more features 480, such as
bosses, (FIG. 4c) that may also be molded, to help position a medical
device in the case.

[0059] While the illustrated embodiment of FIGS. 4A-4C shows cap 450 as a
separate piece, cap 450 may be integrated or attached to case body 430 at
an attachment point, e.g., with a hinge or the like. Accordingly, when
cap 450 is coupled (e.g., using a snap fit, friction fit, interference
fit, or the like, including combinations thereof) onto body 430, the
carrying case is sealed to provide watertight protection for a medical
device sealed therein. The sealed medical device may be operated from
outside the case, and may be worn in water. Cap 450 and/or body 430 may
include a sealing member, e.g., an elastomeric sealing member such as an
elastomeric gasket, lip, ledge including overlapping edge, ridge,
material interface, viscous sealant, and the like, or combinations.

[0060] If case 400 includes an in vitro analyte test strip port access
portion 405 that includes a cut-out 425, a covering 470, such as an
insertable plug, may be provided and dimensioned to be coupled with the
cut-out 425 to close the cut-out 425 to provide a water-tight seal of the
cut-out 425. Covering 470 and/or cut-out 425 may include a sealing
member, e.g., an elastomeric sealing member such as an elastomeric gasket
or the like. The covering 470 is shown as a separate piece, but may be
attached about the cut-out 425 at an attachment point, e.g., with a hinge
or the like.

[0061] In certain embodiments, a multi-shot injection molding process may
be employed to produce case 400. Such a process includes at least first
and second shots or injections of one or more types of materials, which
may occur independently or simultaneously and without regard to ejection
of the finished carrying case. This process is particularly useful if it
is desired to have the case body 430 and one or more other portions of
the case, such as a window 407 or button holes 440, made of different
materials. For example, the case body 430 may be made of an opaque
material and/or a rigid material that does not permit activation, i.e.,
does not enable visibility or physical manipulation, of a carried medical
device, while the activation permissible areas of the case, i.e., window
407 and button holes 440, may include a transparent and/or flexible
material. In such a process, a mold is provided having a shape,
dimensions and features, e.g., cut-outs, openings, voids, bosses 480,
plugs, etc., of the carry case to be produced. For example, as shown in
FIG. 4c, the mold may be designed to include a shaped receptacle to
receive material to form an attachment member 410 on an exterior surface
of case body 430. Other voids or depressions in the case mold may be
provided to form a corresponding shaped void or opening in case body 430,
which voids and openings are then used to make other desired features,
e.g., window 407, button holes 430, etc., of the resulting finished
carrying case. Where the void or opening in the mold is to provide a
corresponding opening in the finished carrying case, i.e., which opening
is to remain clear of any injectable material, a temporary or removable
plug or covering may be provided in the mold to prevent the ingress of
material in its fluid or injectable state. For example, in order to
maintain the test strip access portion cut-out 425 free of debris during
the injection molding process, a temporary plug or covering may be used
which may later be replaced by plug or covering 470 for use with the
finished carrying case.

[0062] In one embodiment, a first shot of a material may be injected or
blown into a carrying case mold to provide the structure defining the
case body 430, and a second shot of a material may then be injected or
blown into the mold to produce a window or lens 407 (e.g., a clear
window) to enable visibility to a medical device held within the
compartment 460 formed by the case body 430. In certain embodiments, the
first injected material, i.e., that used to form the case body 430, may
be made of an opaque or non-transparent, rigid material, e.g., a hard
plastic, to ensure the structural integrity of the contained medical
device. In order to provide the device viewing window or lens 407, the
second injected material may be clear or transparent, e.g., a
thermoplastic elastomer, or silicone, or the like. The mold may also be
configured to provide a carrying case having access holes or voids 440
for receiving or covering or registering with user interface keys or
buttons provided on a user interface surface of the medical device to be
carried within the finished case in order to allow the buttons to be
pushed from outside the case. In which case, the second shot of material,
if also soft or flexible, may be used to make these features or
overmoldings 440 to accommodate the user interface features. The area of
the button hole(s) 440 may have a thickness that is less than the
thickness of case body 430, at least adjacent surrounding areas of the
holes, and in certain embodiments may be thinner than the entirety of the
material of the case body, oftentimes thinner than window area 407 as
well. If both the case and the lens are to be made of a rigid and
transparent material, then only a single shot of material may be
necessary, with the second shot of material used exclusively to form the
overmoldings 440 for the user interface features. In still another
embodiment, if the case body 430 is to be formed of a colored or opaque
material, regardless of whether the material is rigid or compliant, and
the lens is be required to be rigid and transparent, with the overmolding
features 440 required to be made of a clear, soft material, then the case
fabrication process may require at least three injections or shots, each
of a different kind of material. It is noted that any two or more of the
case components, including the case body, window/lens, overmoldings
and/or plugs/coverings, may be separately molded and subsequently welded
together to provide a finished assembly that is sealed water-tight.

[0063] FIGS. 5A and 5B show another exemplary embodiment of a medical
device carrying case 600 according to the subject disclosure. In many
embodiments, case 600 is at least water resistant and in certain
embodiments is water tight when closed.

[0064] FIG. 5A shows a frontal view of case 600 in a closed configuration.
Case 600 includes housing 608, which may be flexible and/or deformable
and/or rigid. Housing 608 includes a frontal or first wall 601 joined
with second or rear or back wall 602 at connector portion 603. Connector
portion 603 may be in the form of a hinge, or the like. The motion may be
limited, e.g., to about 90° (or more or less in certain
embodiments), so that when case 600 is positioned on an article of
clothing such as a belt, and is open, the face of the medical device
carried thereby is up towards the user face. An in vitro analyte test
strip port access portion with a cut-out (not shown) may be provided in
certain embodiments. Also a lanyard connector 700 for attaching a lanyard
(not shown) may be included. In certain embodiments, housing 608 also
includes inter-engageable connector 604 that may be a snap fit assembly
so that the first wall 601 may be releasably joined to second wall 602 by
the snap-fit. A snap fit assembly may be a planar snap fit assembly,
torsion snap fit assembly, annular snap fit assembly, cantilever snap fit
assembly, and the like. A sealing member may be provided.

[0065] FIG. 5B shows a rear perspective view of case 600 in an open
configuration. Attachment member 610 is mounted to back wall 602. Also
shown is the interior space of housing 608 with a medical device 550,
herein shown as an in vitro analyte testing meter, having a test strip
port 551. In certain embodiments, case 600 may include storage area 609
such as shown in the interior space of the case to hold one or more
analyte test strips 50 and/or lancing device (not shown), and/or other
components used to carry out analyte testing.

[0066] In certain embodiments of the present disclosure, a medical device
carrying case for carrying an encased medical device having an integrated
in vitro analyte test strip port may comprise a housing having a first
wall and a second wall, a connector portion that joins the first and
second walls together to provide a compartment to accommodate a medical
device having an integrated in vitro analyte test strip port, and an in
vitro analyte test strip port access portion provided in the housing, the
test strip port access portion comprising a cut-out that is configured to
permit passage of an in vitro analyte test strip therethrough.

[0067] One aspect may further comprise a closeable fastener to selectively
interconnect the first and second walls together.

[0068] In another aspect, the closeable fastener may comprise an
inter-engageable connector positioned about the perimeters of the first
and second walls.

[0069] In another aspect, the inter-engageable connector may comprise a
zipper.

[0070] In yet another aspect, the zipper may comprise dual sliders that
move independently of each other.

[0071] In another aspect, the in vitro analyte test strip port access
portion may be immoveable.

[0072] In another aspect, the in vitro analyte test strip port access
portion may be moveable to selectable positions about the carrying case.

[0073] In yet another aspect, the carrying case may comprise a transparent
window to permit viewing of the medical device carried in the carrying
case.

[0074] In another aspect, the transparent window may be made of a material
that permits manipulation of a user interface of the medical device
carried in the carrying case from outside the carrying case.

[0075] In another aspect, at least a portion of the housing may comprise a
material that permits manipulation of a user interface of the medical
device when carried in the carrying case from outside the carrying case.

[0076] Another aspect may further comprise an attachment member to attach
the carrying case to an article of clothing.

[0077] In one aspect, the attachment member is configured to enable the
case to be swivelable.

[0078] Another aspect may further comprise a covering to provide a
water-tight seal about the cut-out.

[0079] In certain embodiments of the present disclosure, an analyte meter
carrying system may comprise an analyte meter comprising an integrated in
vitro analyte test strip port and a user interface, and a carrying case
comprising first and second walls that define a cavity to hold the
analyte meter, wherein the carrying case is configured to allow
manipulation of the user interface of the analyte meter from outside the
carrying case when the analyte meter is in the carrying case.

[0080] In one aspect, the carrying case may comprise a test strip port
access portion that is configured to permit passage of an in vitro
analyte test strip therethrough to engage with the in vitro analyte test
strip port of the analyte meter when the analyte meter is in the carrying
case.

[0081] In another aspect, the test strip port access portion may comprise
a cut-out.

[0082] In another aspect, the carrying case may comprise a covering to
seal the test strip access portion.

[0083] In one aspect, the analyte meter may be a component of an in vivo
analyte monitoring system.

[0084] In another aspect, the analyte meter may be integrated with an in
vivo analyte monitoring system receiver unit.

[0085] In yet another aspect, the carrying case may further comprise a
stretchable side wall interconnecting the first and second walls.

[0086] In certain embodiments of the present disclosure, a method of
testing for an analyte may comprise positioning a medical device
comprising a test strip port into a carrying case, inserting a test strip
through a test strip access portion of the carrying case and into the
test strip port of the medical device, and testing for an analyte using
the test strip.

[0087] One aspect may further comprise removing a covering from the test
strip access portion of the carrying case prior to inserting the test
strip.

[0088] In another aspect, positioning the medical device into the carrying
case may comprise expanding a stretchable portion of the carrying case.

[0089] Another aspect may further comprise manipulating a user interface
of the medical device from outside the carrying case.

[0090] In certain embodiments of the present disclosure, a method of
fabricating a carrying case for a medical device may comprise injecting a
first material into a carrying case mold to produce a case body defining
a compartment for receiving the medical device, the case mold having at
least one feature to provide a corresponding at least one void within the
produced case body, and injecting a second material into the carrying
case mold to produce a user-accessible area at the at least one void of
the case body, wherein the user-accessible area enables user access to
the medical device when operatively positioned within the carry case.

[0091] In one aspect, injecting the first material and injecting the
second material may occur independently of each other.

[0092] In another aspect, injecting the first material and injecting the
second material may occur simultaneously.

[0093] In one aspect, the user-accessible area may enable visibility of
the medical device.

[0094] In one aspect, the second material may be a transparent material.

[0095] In another aspect, the medical device may include a display and
wherein the user-accessible area of the carrying case is configured to
substantially align with the display of the medical device when the
medical device is operatively positioned within the compartment.

[0096] In certain aspects, the user-accessible area may enable
manipulation of the medical device.

[0097] In another aspect, the second material may be a flexible material.

[0098] In one aspect, second material may have a thickness that is less
than the thickness of first material.

[0099] In one aspect, the medical device may include a user interface and
wherein the user-accessible area of the carrying case is configured to
substantially align with the user interface when the medical device is
operatively positioned within the compartment.

[0100] In another aspect, the user interface may include input keys and
wherein the user-accessible area includes receptacles positioned for
aligning with the input keys.

[0101] In another aspect, the second material may include a thermoplastic
elastomer.

[0102] In another aspect, the first material may include a rigid plastic
material.

[0103] In another aspect, the first material and the second material may
be waterproof.

[0104] In one aspect, injecting the second material may provide a
water-tight seal between the case body and the user-accessible area.

[0105] One aspect may further comprise injecting a third material into the
carrying case mold.

[0106] In one aspect, injecting the third material may produce a second
user-accessible area of the medical device at at least one void.

[0107] Another aspect may further comprise providing a sealing member for
enclosing the compartment to provide a water-tight carrying case.

[0108] Another aspect may further comprise forming an attachment member on
an exterior surface of the case body, the attachment member configured to
attach the carrying case to an article of clothing.

[0109] In one aspect, injecting the first material may form the attachment
member.

[0110] Certain embodiments of the present disclosure include a method of
fabricating a carrying case for a medical device comprising providing a
carrying case mold having at least one void, providing a plug at the at
least one void, injecting at least one material into the carrying case
mold to produce a case body defining a compartment for receiving the
medical device, and removing the plug to provide a cut-out within the
resulting case body, for physically accessing a portion of the medical
device when the medical device is operatively received within the
compartment.

[0111] In one aspect, the medical device may comprise an integrated in
vitro analyte test strip port which is accessible via the cut-out when
the medical device is operatively received within the compartment.

[0112] The carrying cases described herein may be any suitable shape to
provide a secure fit for a particular medical device, and may vary
depending on the shape of the medical device to be carried thereby. In
the embodiments illustrated herein, the carrying case are shown as
substantially rectangular in shape, however other shapes are contemplated
as well. The carrying cases are shaped and dimensioned to provide a body
having contours corresponding generally to the contours of a medical
device to be carried therein.

[0113] Also, it is contemplated that any optional feature of the inventive
variations described may be set forth and claimed independently, or in
combination with any one or more of the features described herein.
Reference to a singular item, includes the possibility that there are
plural of the same items present. More specifically, as used herein and
in the appended claims, the singular forms "a", "an", "said", and "the"
include plural referents unless the specifically stated otherwise. In
other words, use of the articles allow for "at least one" of the subject
item in the description above as well as the claims below. It is further
noted that the claims may be drafted to exclude any optional element. As
such, this statement is intended to serve as antecedent basis for use of
such exclusive terminology as "solely", "only" and the like in connection
with the recitation of claim elements, or use of a "negative" limitation.
Without the use of such exclusive terminology, the term "comprising" in
the claims shall allow for the inclusion of any additional
element--irrespective of whether a given number of elements are
enumerated in the claim, or the addition of a feature could be regarded
as transforming the nature of an element set forth n the claims. Stated
otherwise, unless specifically defined herein, all technical and
scientific terms used herein are to be given as broad a commonly
understood meaning as possible while maintaining claim validity.

[0114] Various other modifications and alterations in the structure and
method of operation of the embodiments of the present disclosure will be
apparent to those skilled in the art without departing from the scope and
spirit of the present disclosure. Although the present disclosure has
been described in connection with certain embodiments, it should be
understood that the present disclosure as claimed should not be unduly
limited to such embodiments. It is intended that the following claims
define the scope of the present disclosure and that structures and
methods within the scope of these claims and their equivalents be covered
thereby.

Patent applications by Gary Ashley Stafford, Hayward, CA US

Patent applications by Mark Kent Sloan, Redwood City, CA US

Patent applications by Abbott Diabetes Care Inc.

Patent applications in class With detail of sampling, sample handling, or sample preparation

Patent applications in all subclasses With detail of sampling, sample handling, or sample preparation